Title: Verification Engineer
Location: Cambridge, MA
Duration: 5 Months
Experience: 3-5 years professional experience. Education: Bachelor's Degree or equivalent unless otherwise specified.
Join our connected sensing team and help develop wearables to solve some of the most difficult healthcare issues we face today. Setup like a start-up and working along other innovators in Boston/Cambridge, we are leading the innovation in Healthcare.
You are responsible for
• Support all aspects of product development from initial concept through final system verification, FDA submission and product launch.
• Responsible for HW and SW product requirement review with an emphasis towards clarity, complexity and testability of specifications.
• Responsible for developing and executing a comprehensive testing strategy for product requirements including writing test protocol specifications, identifying / developing testing tools and resources, as well as automation scripts where applicable.
• Responsible for documentation of all verification testing activities as well as development of a complete tractability map for all product requirements and associated tests. This includes product hazard analysis, mitigations and verification activities.
• Responsible for supporting cross-functional team activities including scheduling, planning, status updates, defect triage, sprint standups and milestone demos.
You are a part of
The Connected Sensing Venture is designed to serve and enable our HealthTech customers and Philips businesses to capture the emerging value in the increasingly digital, connected world of wearable monitoring. The venture will work to collaborate across HealthTech to re-imagine, develop and deliver connected sensing solutions for our professional customers.
All around us, we are experiencing a transformation in how healthcare is delivered and consumed. Industry experts believe that wearables and connected bio-sensing solutions will help solve critical clinical challenges; the ones that are increasing preventable suffering, anxiety and costing billions of dollars every year.
To succeed in this role, you should have the following skills and experience
• 5+ years of experience in the medical solutions space working on system verification related activities in FDA regulated environments.
• Demonstrated experience of working collaboratively within cross-functional teams, to deliver medical products with high quality
• Solid understanding of FDA, IEC and ISO related standards and testing in medical systems.
• Background in embedded device development and testing preferred.
• Strong background in quality management, configuration management and document control systems in a regulated, 510k submission environment.
• Strong background in creating / maintaining test protocol, requirement tractability and defect tracking documents, tools and databases.
• Exposure to Agile team environments and development practices preferred.
• Strong interpersonal, communication, and technical writing skills.
• Understanding of network environments and protocol testing, including BLE, Ethernet, both wired and wireless preferred.